Secrets of the FDA Revealed by Top Insider Doctor: Part 5

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Secrets of the FDA Revealed by Top Insider Doctor: Part 5

 

 

According to the Journal of the American Medical Association (JAMA),

" Adverse drug reactions are the fourth leading cause of death in

America. Reactions to prescription and over-the-counter medications

kill far more people annually than all illegal drug use combined. "

 

Annually, drug companies spend billions on TV commercials and print

media. They spend over $12 billion a year handing out drug samples and

employing sales forces to influence doctors to promote specifically

branded drugs. The drug industry employs over 1,200 lobbyists,

including 40 former members of Congress. Drug companies have spent

close to a billion dollars since 1998 on lobbying. In 2004, drug

companies and their officials contributed at least $17 million to

federal election campaigns.

 

To get a full diagnosis of this provocative story, highly acclaimed

health guru Gary Null sent his lead investigator and Director of

Operations, Manette Loudon, to Washington, D.C. to interview FDA

employee and Vioxx whistleblower Dr. David Graham. What you are about

to read may leave you questioning the safety of all drugs, but it is a

story that must be told. Unless Congress steps up to the plate and

changes policy at the FDA, millions more will become unwitting victims

of adverse drug reactions from unsafe drugs.

 

Manette Loudon: What do you think people hear when they're watching

the ad and after the ad they list all the possible side effects?

 

Dr. Graham: I don't think it registers.

 

You have the visual image that conveys one message. Then you have the

voice that's speaking over this pictorial being shown telling you what

this drug is good for. Then, at the end, the auctioneer gets on and

says, " You know this drug could cause?, " and they rattle off 25

different things in three seconds. You're lucky if you hear anything.

 

I don't think that people come away with it and they certainly don't

come away with any sense of how likely it is to happen because the

visual image overpowers anything that gets said.

 

It's the same with the ads that appear in magazines. Companies are

required to put some of the labeling in the ad. You have the ad on the

one side -- that's the picture. It shows this person being healthy

because they take this pill. The fine print is all on the next page.

People aren't going to read the fine print.

 

It's the same thing with labeling for physicians. Physicians don't

read product labels. Where do they learn about drugs? They learn about

drugs from the detail person from the drug company or from other

colleagues who have used the drug. They're not learning it from the

labeling.

 

Loudon: Do you think there is a criminal cover-up going on between the

FDA and Big Pharma to approve dangerous drugs that sicken and kill

Americans?

 

Dr. Graham: I have no knowledge of criminal activity and I'm sure

there are legal standards for what's criminal and what's not. I do

think that there is an institutional bias at the FDA that says we will

look for a way to say " yes " to the approval of any drug that comes

down the pipe. If a drug is so bad that they can't find a reason to

approve it, they won't. But, if there is any way that they can approve

the drug, they will.

 

The way this is done is by what's called the " indication. " Why is it

that you're going to take the drug? Maybe, you're going to take it

because you have high blood pressure. Maybe, you'll take it because

you have high cholesterol. That's the indication.

 

A company may come in with a drug and want to get it approved for five

different indications. One of them is a really insignificant

indication that affects a very small number of people. The main

indication might affect millions of people. The drug doesn't show

efficacy for that major indication, but they're able to somehow or

another approve the small indication.

 

So the drug gets approved for this narrow indication, but the FDA and

the drug company both know that it's going to be used for that other

indication. It's going to be used " off-label. " Then, the FDA turns

around and says that they don't regulate the " off-label " use of drugs.

No. But, they aid and abet it. They allow it to happen and, in many

instances, " off-label " use of a drug product is a public health threat.

 

The FDA has a responsibility to protect the public health. The FDA

should be intervening, but they don't. In my own experience, I have

seen multiple examples where I've heard people say, " We can't ask a

company to put that in the labeling because the company will say no. "

Or, " We can't do that because that will decrease their marketing.

We've got to try to approve this drug. Let's see if we can give them

this small indication. At least it's giving them something. You've got

to find a way to say yes. "

 

That is the typical attitude of the FDA culture. I think Congress is

partially responsible for that because when they issued the PDUFA, the

Prescription Drug User Fee Act, what they were really saying was, " We

want you to review these drug applications more quickly because you're

keeping lifesaving medicines from the American people. "

 

That's the line they were fed by Big Pharma. So they pressure the FDA,

and the FDA gets the message. It's a really pernicious system. I think

it's unfortunate.

 

There are many people from the FDA who have examples that they

unfortunately can't talk about. They'd lose their job and maybe get

thrown in prison because you can't discuss confidential and trade

secret information. But the fact is, these things happen at the FDA

and there have been multiple examples in the past where one could see

evidence of that.

 

Loudon: Did your faith as a devout Roman Catholic play any role in the

decisions you made to put your career on the line to report the truth?

 

Dr. Graham: It did in so far as my faith forms my conscience. It's

sort of my sense of what's right and what's wrong and what I am and am

not responsible for. I was in a situation here with Vioxx where I was

invited by Sen. (Chuck) Grassley's (R-Iowa) office to testify. I could

have told them no, but then they would have subpoenaed me. So, of

course, I went peaceably.

 

I was faced with this dilemma. Should I lay it on the line and tell

them the way it really is, or do I kind of downplay it? There are ways

of doing that.

 

What I concluded was that I'm now being given the opportunity to tell

the truth to the people who are in a position to actually make a

difference. I can't make a difference. I can't change the FDA, but

Congress can. If I don't tell them the truth, then I'm now

responsible, in part, for future deaths.

 

I don't want to become a co-conspirator with the FDA in what happens

with Vioxx because tens of thousands of people were injured or killed

because of the FDA's disregard for safety. If I keep quiet about that,

now I'm part of the problem. I'm one of them, and, at that point, then

my conscience asks me, " You know what the truth is, are you going to

speak it or aren't you? " So I went ahead and did that and prayed that

it all works out well for me personally. That I have a job and I'll be

able to support my family, that I'm protected from retaliation, that

maybe some good will come out of that.

 

My faith plays a role, but it wasn't a direct teaching of the church.

You have to do x, y and z, but it's the faith as I've internalized it.

My conscience is formed by the voice of Christ speaking internally to

me. That's what the conscience is: It's the voice of God speaking to

each and every one of us about what's right and what's wrong.

 

I knew what was right. If I walked away from that, nobody else would

have to do anything. I'd be beating myself up because my conscience

would condemn me. So, yes, faith plays a part in every thing that I do.

 

It's not saying I'm a saint, because I'm not. But I can't separate who

I am from my religious faith. It's all part of the same person.

 

Crusador would like to thank Manette Loudon and Pam Klebs for their

help in putting this interview with Dr. David Graham together.

 

Crusador is a hard-hitting, in-depth health publication that cuts

through the health lies that are so prevalent in our world today.

Crusador is published every two months. To obtain a free sample or to

to this one-of-a-kind publication visit their Web site.

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Dr. Mercola's Comment:

 

Dr. David Graham has also helped write new legislation called the

Grassley Dodd Bill that is currently held up in committee. It is a

radical bill that should help transform the Food and Drug

Administration (FDA) back to its roots and really protect the public

safety. It would set up a new independent Center inside the FDA to

review drugs and biological products once they are on the market.

 

The bill addresses the fact that the Office of New Drugs carries too

much sway over the FDA's drug-safety apparatus. Today, drug makers

have the ability to negotiate with the FDA officials who approved

their drugs to begin with when the FDA considers corrective action. By

creating a Center for post-market review, this legislation puts you,

the American consumers, where you belong at the FDA, and that's front

and center.

 

I don't ask you to write your congressman frequently, but this one is

worth it. You can help save some lives by helping to increase pressure

to change the way the FDA is run. The drug companies do NOT want this

bill passed and they have the largest lobby in Congress, so we really

need all the help we can get.

 

You can find out how to contact your Congressman by going to the

following URL:

 

* http://www.house.gov/writerep/

 

All you need to do is write a simple short note telling them how you

feel the FDA is critically broken and you believe that the new

proposed legislation would really help improve that.

 

If you want to review the entire bill, it is up on the site.

 

Related Articles:

 

The FDA " Foxes " Keep Guarding the Drug Safety " Henhouse "

 

Testimony of David J. Graham, MD, MPH

 

Vioxx Reapproved by FDA Panel Members With Ties to Drug Companies